Drug Substance Cmc Lead
vor 1 Woche
Drug Substance CMC Lead
Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them.
Key Responsibilities
- Responsible for drug substance CMC development activities from late stage to product licensure.
- Resource planning, project timelines and budget.
- Staff management.
- Writing/reviewing and approval of technical protocols and reports.
- Writing/reviewing of CMC sections (module 3) of regulatory submissions and responses to any agency questions.
- Provide input to project feasibility and suggest changes to ensure successful completion of assigned projects.
- Interface with project governance committees (internal and external) as required
- Provide scientific leadership and direction to the CMC Development team in order to advance the company's platforms as well as the current and future product portfolio.
- Ensure all activities are carried out to company's global quality and safety standards.
Position Qualifications
Education/Learning Experience/Work Experience
- Required:_
- PhD/Master in Biotechnology or equivalent.
- 15 years plus experience in late stage development and GMP manufacturing of pharmaceutical products.
- Familiarity with regulatory guidance's pertaining to the Chemistry, Manufacturing and Control of manufacture pharmaceutical products.
- Experience in project management of complex technical projects involving several internal and external stakeholders.
- Experience in working with C(D)MO's and CLO's.
- Required: _
- Excellent communication, negotiation and conflict management skills.
- Ability to think strategically, create innovative strategies, drive changes, manage ambiguity and able to anticipate future trends and consequences.
- Ability to work crossfunctionally in a matrix environment.
- Excellent leadership skills with the ability to motivate, inspire and manage a team.
- Excellent verbal and written communication skills in English; French, Swedish, German is a plus.
- Required:_
- Excellent understanding of development processes and challenges
- Problem solving, creative, flexible with regards to evolving priorities
- Organized, detail oriented and structured working style
- Deliver results in a complex business network
- Foster collaboration and teamwork and engage internal and external expertise as needed
- Perceive change as an opportunity for improvement and successfully manage ambiguity
- You must demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.
Recruitment contact & how to apply
Sobi is an affirmative action and equal opportunity employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, or national origin.
Sobi is committed to providing access, equal opportunity and reasonable accommodation for individuals with disabilities in employment, its services, programs and activities.
Why Join Us?
We are a global company with around 1,500 employees in more than 30 countries, and are committed to the societies where we operate.
With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we're ready to take on the world's diseases, ailments and adversity.
Our people believe they have the power to make a positive impact in others' lives because that's exactly what we do here.
If you're seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.
We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.Sobi Culture
At Sobi, we refuse to accept the status quo.
This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.
As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength.By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them.
This has been our approach since day one, but we know we can't change the world of rare diseases on our own.
Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilit
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